Derek Ansel Working to Establish Clinical Trials for Those Having to Battle Rare Diseases
By Chuck Carlson
It can be a long, expensive process, even in the best of situations, to get a new drug on the market and in the hands of the people who need it.
Imagine the process of drug study, trial, and testing before facing the strict requirements of the Food and Drug Administration for a disease that affects fewer than 200,000 people nationally.
That is among the challenges for Worldwide Clinical Trials, an international contract research organization, and its newly installed Therapeutic Lead Strategy in Rare Disease Vice President, Derek Ansel.
Ansel is a 2019 graduate of Michigan State University’s Pharmacology & Toxicology Department’s Online Master’s Program, where he studied the fundamental principles of Pharmacology and learned about the drug discovery and approval process. He took what he learned from MSU to earn a second master’s from Bay Path University in Massachusetts, where he studied genetic counseling.
“I was interested in how drugs get into clinical trials,” he said, adding that his capstone project at MSU was on the impact of those trials on gene therapy products for the treatment of hemophilia and what that novel therapy can bring to the overall care of the patient.
He credits former MSU online master’s program director, Dr. Jane Maddox, with helping him understand the process by which drugs go through pre-clinical testing. He recalls how one particular course, focused on pharmacogenomics, was vital for him as he looked to his career in clinical trials and genetics.
“It was a course on how genes control drug metabolism,” he said. “It was a very forward-thinking topic that was done very well at Michigan State.”
Ansel eventually took those skills to Worldwide Clinical Trials where he works with pharmaceutical companies to establish clinical trials for people afflicted with these rare diseases, the long list of which can still impact some 25 to 30 million Americans.
It can take years and millions of dollars before the FDA puts its final stamp of approval on a drug. For many families with loved ones with a rare disease (many of whom are children), Ansel admits the process can take longer than the patient has time to wait.
That’s where his training from MSU helps.
“Bittersweet is always the word I think of,” he said. “There has been so much work that has been paved by parents who have no other option. But there is also so much hope, and so much of that has been driven by parents and caregivers. Sometimes there’s no meaningful treatment option, but I find it inspiring that there’s such a commitment for patient communities to be involved in the drug development process.”
And for Ansel and his team of researchers, the goal is to help them find an answer.
It begins with the pharmaceutical company contacting Ansel about a drug it wants to place in clinical trials.
“We’re the connection between academic institutions and the pharmaceutical company,” he said. “We talk to chief science officers, chief medical officers, and ultimately teams that run the trials with the goal of strategizing the clinical development program towards drug approval. Once the study is set up and patients are receiving the investigational drug, we monitor patient safety. We go to the institution and document how patients are progressing through the study. We work very closely with the medical institutions and make sure patients are safe and the data are accurate. The long-term goal is always to get the drug approved.”
It can be a lengthy process and there are no guarantees the drug will be the answer patients and their families are seeking. But Ansel said when families hear of a drug trial, their response is enthusiastic.
“Word gets out very fast, and families will contact us pretty quickly,” he said, noting that families will often offer to fly wherever they need to go to be involved in the study. “With rare diseases, there’s so much we still don’t know and understand. But patients with these diseases are so committed to finding answers.”